Efficacy and Safety of Dual Antiplatelet Treatment up to 72 Hours in Acute Ischemic Stroke Stratified by Glycemic Status

IF 7.7 1区医学 Q1 CLINICAL NEUROLOGY Annals of Neurology Pub Date : 2025-02-11 DOI:10.1002/ana.27207

Qi Zhou MD, Ying Gao MD, Weiqi Chen MD, S. Claiborne Johnston MD, PhD, Pierre Amarenco MD, Philip M. Bath DSc, Xuan Wang MD, Hongyi Yan MD, Tingting Wang MD, Yingying Yang MD, Yanli Zhang MSc, Qingwu Yang MD, PhD, Mengxing Wang MD, Jing Jing MD, PhD, Chunjuan Wang MD, PhD, Yongjun Wang MD, Yilong Wang MD, PhD, Yuesong Pan PhD

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Abstract

Objective

The objective was to investigate the efficacy and safety of clopidogrel-aspirin versus aspirin alone in patients after ischemic stroke by glycemic status using data from the Intensive Statin and Antiplatelet Therapy for Acute High-risk Intracranial or Extracranial Atherosclerosis (INSPIRES) trial.

Methods

Patients with mild ischemic stroke or high-risk transient ischemic attack (TIA) were randomized to clopidogrel-aspirin or aspirin alone. They were categorized into 3 subgroups according to glycemic status based on medical history and diagnosis by a clinician during hospitalization: without type 2 diabetes mellitus, with newly diagnosed type 2 diabetes, and with a history of type 2 diabetes mellitus. The primary efficacy and safety outcomes were new stroke and moderate-to-severe bleeding risk within 90-day follow-up.

Results

A total of 6,100 patients were enrolled (3,050 in each arm), with a median age of 65 years (interquartile range [IQR], 57–71) and 2,185 female (35.8%). Clopidogrel-aspirin treatment was associated with a reduction in recurrent stroke compared with aspirin alone in patients without type 2 diabetes mellitus (6.3% vs 8.4%; hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.59–0.94; p = 0.01) and those with newly diagnosed type 2 diabetes mellitus (5.8% vs 13.0%; HR, 0.30; 95% CI, 0.14–0.66; p = 0.002), but not in those with a history of type 2 diabetes mellitus (10.0% vs 9.9%; HR, 0.98; 95% CI, 0.72–1.33; p = 0.88) (p for interaction = 0.03). Moderate-to-severe bleeding events did not differ significantly by treatment across glycemic subgroups.

Interpretation

In the INSPIRES trial, patients without or with type 2 diabetes mellitus derived greater benefit from clopidogrel-aspirin than those with a history of type 2 diabetes mellitus after mild ischemic stroke or high-risk TIA.

Trial Registration

INSPIRES, NCT03635749. Registered 15 August 2018, https://clinicaltrials.gov/search?cond=NCT03635749. ANN NEUROL 2025;98:174–182

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按血糖状态分类的急性缺血性脑卒中患者72小时内双重抗血小板治疗的有效性和安全性。

目的：目的是利用急性高危颅内或颅外动脉粥样硬化强化他汀类药物和抗血小板治疗（inspire）试验的数据，通过血糖状态调查氯吡格雷-阿司匹林与阿司匹林单独治疗缺血性卒中患者的有效性和安全性。方法：将轻度缺血性卒中或高危短暂性脑缺血发作（TIA）患者随机分为氯吡格雷-阿司匹林组和阿司匹林单用组。根据住院期间的病史和临床医生的诊断，将患者的血糖状况分为3个亚组：无2型糖尿病、新诊断为2型糖尿病和有2型糖尿病病史。主要疗效和安全性指标为90天随访期间新发卒中和中重度出血风险。结果：共纳入6100例患者（每组3050例），中位年龄为65岁（四分位间距[IQR]， 57-71），女性2185例（35.8%）。在没有2型糖尿病的患者中，与单独使用阿司匹林相比，氯吡格雷-阿司匹林治疗与卒中复发的减少相关(6.3% vs 8.4%；风险比[HR]， 0.75；95%置信区间[CI]， 0.59-0.94；P = 0.01)和新诊断的2型糖尿病患者(5.8% vs 13.0%；人力资源,0.30;95% ci, 0.14-0.66；P = 0.002)，但有2型糖尿病史的患者没有(10.0% vs 9.9%；人力资源,0.98;95% ci, 0.72-1.33；P = 0.88)（相互作用P = 0.03）。在不同的血糖亚组中，中重度出血事件没有显著差异。解释：在inspire试验中，与有2型糖尿病病史的患者相比，无2型糖尿病患者在轻度缺血性卒中或高风险TIA后服用氯吡格雷-阿司匹林获益更大。试验注册：inspire， NCT03635749。2018年8月15日注册，https://clinicaltrials.gov/search?cond=NCT03635749。Ann neurol 2025。

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来源期刊

Annals of Neurology 医学-临床神经学

CiteScore

18.00

自引率

1.80%

发文量

270

审稿时长

3-8 weeks

期刊介绍： Annals of Neurology publishes original articles with potential for high impact in understanding the pathogenesis, clinical and laboratory features, diagnosis, treatment, outcomes and science underlying diseases of the human nervous system. Articles should ideally be of broad interest to the academic neurological community rather than solely to subspecialists in a particular field. Studies involving experimental model system, including those in cell and organ cultures and animals, of direct translational relevance to the understanding of neurological disease are also encouraged.